The United States Food and Drug Administration (FDA) requires US Agents for foreign companies who wish to sell or involve in the manufacturing/testing of drugs or pharmaceuticals, medical devices, food, and dietary supplements, in the United States. US Agent also requires for foreign applicants who wish to file NDA or IND with the FDA. The US Agent acts as a communicator between the FDA and foreign companies.
All FDA communications – such as compliance issues, product-related problems, or inspection schedules – will come through the US Agent, so foreign companies should make sure that the appointed US Agent has a clear understanding on all regulatory compliance matters.
Docent Pharma will assist you in;
- Drug Establishment Registration
- Cosmetic Registration
- NDC-Labeler Code Request
- Medical Device Registration
- Food/Dietary Supplement/Nutraceuticals Facility Registration
- FDA Regulatory Submissions (NDA, ANDA, NADA, and ANADA, IND, DMF)
We offer cost-effective & high-quality US Agent services to clients around the world. We’re ready to work with you! To appoint us as your US Agent; please CONTACT US.